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Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
This study is ongoing, but not recruiting participants.
First Received: December 26, 2007   Last Updated: March 18, 2008   History of Changes
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00590031
  Purpose

Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.


Condition Intervention Phase
Esophageal Carcinoma
Drug: Cisplatin
Drug: Irinotecan
Radiation: External Beam Radiation Therapy
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Radiation Therapy Surgery
Drug Information available for: Cisplatin Irinotecan U 101440E Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Determine pathologic complete response rate for subjects on study [ Time Frame: Conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate toxicity and tolerability including surgical morbidity and mortality [ Time Frame: Conclusion of study ] [ Designated as safety issue: Yes ]
  • Determine overall survival, disease free survival, and pattern of failure. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
  • Assess parameters of quality of life using the Dysphagia scale, and FACT-E questionnaires [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: November 2002
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
External Beam Radiation Therapy, Cisplatin, Irinotecan
Drug: Cisplatin
pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
Drug: Irinotecan
Irinotecan will be given 65 mg/m2
Radiation: External Beam Radiation Therapy
will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be able to sign the informed consent document.

Exclusion Criteria:

  • Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound, or CT scanning.
  • Cervical esophageal tumors,
  • Gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus.
  • Prior chemotherapy or radiation.
  • Patients with evidence of metastatic disease are not eligible. This includes:
  • Positive malignant cytology of the pleura, pericardium or peritoneum.
  • Radiographic evidence of distant organ involvement including lung, liver, bone, or brain.
  • Patients with involvement of non-regional lymph nodes including supraclavicular or celiac lymph node metastases.
  • Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,
  • New York Heart Association Class III or 1V heart disease. Angina or myocardial infarction within the last 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality.
  • Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant illness whose control may be jeopardized by the complications of this study treatment.
  • Pregnant or lactating women are ineligible as the effect of the drugs used in this study on a fetus or newborn child are unknown. Premenopausal fertile females require a negative pregnancy test prior to study entry. Treatment may not begin until the results of the pregnancy tests are ascertained. Both sexes must use contraception while on this study.
  • History of prior malignancy (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of entrance into this study.
  • Patients with known Gilbert's Disease.
  • Clinically significant hearing loss.
  • Serum calcium_>12 mg/dl.
  • Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
  • Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements.
  • Patients with any other concurrent medical or psychiatric condition or disease, which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590031

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Peter Scardino, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center ( David Ilson MD, PhD )
Study ID Numbers: 02-045, IND 65889
Study First Received: December 26, 2007
Last Updated: March 18, 2008
ClinicalTrials.gov Identifier: NCT00590031     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Esophageal Carcinoma
Cisplatin
Irinotecan
Radiation Therapy
02-045

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Irinotecan
Esophageal Cancer
Carcinoma
Digestive System Diseases
Radiation-Sensitizing Agents
Cisplatin
Esophageal Disorder
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Esophageal Neoplasms
Physiological Effects of Drugs
Irinotecan
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009